FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
131089–131112 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 1989
CLS 962 MICROPLATE PHOTOMETER
K891869 · JJQ
Cambridge Life Sciences Plc.
Chemistry · 43d
Cleared May 09, 1989
MONI-TROL(R)
K891929 · JJY
Baxter Healthcare Corp
Immunology · 42d
Cleared May 09, 1989
TECHNICON DPA-1 (TM) CRP METHOD
K892198 · DCK
Technicon Instruments Corp.
Immunology · 36d
Cleared May 09, 1989
AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)
K892362 · DBF
Amersham Corp.
Immunology · 33d
Cleared May 09, 1989
MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST
K892421 · LJM
Lipogen, Inc.
Immunology · 29d
Cleared May 09, 1989
SPQ TM TEST SYSTEM II FOR CRP
K892526 · DCK
Atlantic Antibodies
Immunology · 28d
Cleared May 09, 1989
RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU
K892542 · FFN
Zinnanti Surgical Instruments, Inc.
Gastroenterology & Urology · 28d
Cleared May 09, 1989
BEST COLON CLAMP
K892550 · FFN
Zinnanti Surgical Instruments, Inc.
Gastroenterology & Urology · 28d
Cleared May 09, 1989
E653 OBLONG ABDUCTION BLOCK
K892697 · INW
Rifton Equipment For the Handicapped
Physical Medicine · 26d
Cleared May 09, 1989
E655 ADJUSTABLE ABDUCTION BLOCK W/HIP STABILIZER
K892698 · INW
Rifton Equipment For the Handicapped
Physical Medicine · 26d
Cleared May 09, 1989
E613 PAIR OF SUPPORT BLOCKS
K892699 · INW
Rifton Equipment For the Handicapped
Physical Medicine · 26d
Cleared May 09, 1989
E65 35 PRONE STANDER
K892700 · INW
Rifton Equipment For the Handicapped
Physical Medicine · 26d
Cleared May 08, 1989
BDAC OMICRON PLUS SURGICAL GLOVES
K885271 · KGO
Bd Becton Dickinson Vacutainer...
General Hospital · 137d
Cleared May 08, 1989
LIGHT SOURCE, ENDOSCOP, XENON ARC
K890448 · FFS
Mira, Inc.
Gastroenterology & Urology · 101d
Cleared May 08, 1989
PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE
K891109 · KNT
Concept, Inc.
Gastroenterology & Urology · 67d
Cleared May 08, 1989
SEAMLESS LATEX PATIENT EXAMINATION GLOVES
K891491 · LYY
Digitcare Corp.
General Hospital · 53d
Cleared May 08, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891936 · LYY
Ku Shing Industries Sdn. Bhd.
General Hospital · 41d
Cleared May 08, 1989
NON-STERILE PATIENT EXAMINATION GLOVES
K891938 · LYY
Lien Chang Rubber Industrial Co., Ltd.
General Hospital · 41d
Cleared May 08, 1989
PATIENT EXAMINATION GLOVES (VINYL)
K891941 · LYZ
Cypress Medical Products, Ltd.
General Hospital · 41d
Cleared May 08, 1989
PATIENT EXAM GLOVES (MFG. JENQ CHUAM INDUSTRIAL)
K891942 · LYY
Lc Saratoga International, Inc.
General Hospital · 46d
Cleared May 08, 1989
PATIENT EXAMINATION GLOVE
K891956 · LYY
Equatorial Rubber Mfg. Industry Sdn Bhd
General Hospital · 41d
Cleared May 08, 1989
NON-STERILE LATEX EXAMINATION GLOVES
K891961 · LYY
Union License Ent. Co., Ltd.
General Hospital · 40d
Cleared May 08, 1989
PATIENT EXAM GLOVES (MFG. SHUN JUN TRADING CO.)
K892100 · LYY
Ergo Intl., Ent., Inc.
General Hospital · 35d
Cleared May 08, 1989
PATIENT EXAM GLOVES (MFG. SHUN TAHI RUBBER GLOVES)
K892101 · LYY
Ergo Intl., Ent., Inc.
General Hospital · 35d